FDA product code MLR: Sterilizer, Chemical
MLR is the FDA product code for sterilizer, chemical. It is a Class II device, regulated under 21 CFR 880.6860 and reviewed by the General Hospital panel. FDA has cleared 47 510(k) submissions under MLR, 12 in the last five years, from 11 different applicants. The average 510(k) review took 212 days (median 196); 179 days on average over the last three years. FDA has posted 46 recalls for MLR devices.
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Chemical |
| Device class | Class II |
| Regulation | 21 CFR 880.6860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MLR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 212 |
| 2018 | 2 | 160 |
| 2019 | 4 | 116 |
| 2021 | 2 | 94 |
| 2022 | 2 | 74 |
| 2023 | 5 | 194 |
| 2024 | 3 | 287 |
| 2025 | 1 | 31 |
| 2026 | 1 | 219 |
Compare with all 510(k) review times · Search every MLR clearance
Top MLR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 17 | 2023-08-07 |
| Advanced Sterilization Products | 13 | 2024-07-05 |
| Advanced Sterilization Products, Inc. | 4 | 2026-04-15 |
| Plasmapp Co,., Ltd. | 4 | 2023-05-25 |
| Steris | 2 | 2023-10-20 |
6 more applicants have MLR clearances. See the full list in Caduvo.
Most recent MLR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252843 | Advanced Sterilization Products, Inc. | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | 2026-04-15 | 219 |
| K250802 | Advanced Sterilization Products, Inc. | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | 2025-04-14 | 31 |
| K231893 | Lowtem Co., Ltd. | LOWTEM Crystal 120 | 2024-09-18 | 448 |
| K234082 | Advanced Sterilization Products | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077) | 2024-07-05 | 196 |
| K233762 | Ideate Medical, Inc. | SteroScope® Sterilization Technology System | 2024-06-27 | 216 |
Recalls for MLR devices
46 product recalls in 33 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-26.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code MLR?
MLR is the FDA product code for sterilizer, chemical. It is a Class II device, regulated under 21 CFR 880.6860 and reviewed by the General Hospital panel.
What device class is MLR?
Class II, regulation 21 CFR 880.6860. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLR?
Across 47 cleared submissions the average was 212 days from receipt to decision (median 196).
Which companies have the most MLR clearances?
STERIS Corporation (17); Advanced Sterilization Products (13); Advanced Sterilization Products, Inc. (4); Plasmapp Co,., Ltd. (4); Steris (2).
Have MLR devices been recalled?
Yes: 46 product recalls across 33 recall events; the most recent began 2018-07-26.
Next steps
- Run an FDA pathway report with predicate devices for product code MLR
- Run a recall and safety report across every MLR manufacturer
- Watch product code MLR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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